Bioceros - Recombinant Protein Production and Preclinical Development of Monoclonal Antibodies

• Generation of PER.C6 or CHO based cell lines that produce high-level recombinant proteins or monoclonal antibodies
• Pre-clinical manufacturing of recombinant proteins up to 20-L scale
• Development and execution of cell-based immuno-assays
• Consultancy services for immune-histochemistry and in vivo proof of concept and toxicology studies (rodents, non-human primates)

Generation of high producing cell lines

Bioceros has extensive experience in the generation of CHO or PER. based cell lines that produce high levels of recombinant protein. Currently, Bioceros is recognized as the only preferred vendor for PER.C6® services by DSM and Crucell in Europe.

We have separate cell culture labs for PER.C6 and CHO activities, which are dedicated for the generation of protein producing cell lines. The cell lines are generated in serum-free culture media, under quality-controlled conditions and are therefore suited for entry in a GMP facility for manufacturing of clinical trial material.

Manufacturing of proteins at 20-L scale

Bioceros produces batches of recombinant proteins for pre-clinical use from PER.C6 and CHO based cell lines at 20-L scale in disposable bioreactors (Lonza). These state-of-the-art reactors are designed for high cell-density cell cultures and hence high yields (reference).

In addition, Bioceros offers the XD process for PER.C6® based cell lines. This process uses extreme high cell densities (up to 150E6 cells/ml) and therefore offers unequaled high yields of recombinant protein.

XD process for PER.C6

As the XD process is used for clinical manufacturing at DSM Biologics as well, a smooth transfer - and hence short development timelines - for clinical manufacturing is evident.

Development and execution of cell-based assays

Bioceros has vast experience in the development and execution of cell-based potency assays, including use of primary human cells.

Consultancy for pre-clinical development of Monoclonal Antibodies

Bioceros has wide experience in pre-clinical development of monoclonal antibodies, including GLP-compliant immuno-histochemistry and in vivo proof of concept and toxicity testing in animals (rodents, non-human primates). These studies are not done in-house but this knowledge is offered to customers as a consultancy service.